Study Stopped
No accrual
Educational Brochure in Preparing Patients With Gastric Cancer and Their Caregivers for Recovery After Surgery
Pilot Study of an Educational Brochure to Prepare Patients and Informal Caregivers for Recovery Following Gastrectomy
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
This pilot clinical trial studies an educational brochure in preparing patients with gastric cancer and their caregivers for recovery after surgery. Giving an educational brochure may help prepare patients and their caregivers by improving knowledge about symptoms after surgery. It may also improve quality of life and reduce worry after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 6, 2015
CompletedFirst Posted
Study publicly available on registry
January 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedSeptember 25, 2015
September 1, 2015
8 months
January 6, 2015
September 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient/informal caregiver satisfaction with timing, content, and delivery of the intervention
Descriptive statistics will be presented through summary statistics of data from the satisfaction tools.
Up to 2 months
Secondary Outcomes (1)
Change in mean survey scores
Baseline up to 4 weeks
Study Arms (2)
Cohort I (standard care)
ACTIVE COMPARATORParticipants receive standard post-operative care.
Cohort II (educational brochure)
EXPERIMENTALParticipants receive a 2-page educational brochure after surgery and prior to discharge home.
Interventions
Receive educational brochure
Ancillary studies
Eligibility Criteria
You may qualify if:
- Scheduled to undergo partial or total gastrectomy for treatment of gastric cancer
- Able to read and understand English
- The primary informal caregiver as identified by patients participating in the study; this refers to either a family member or friend who will be providing the majority of care following surgery
- Able to read and understand English
- All participants must have the ability to understand the willingness to provide informed consent
You may not qualify if:
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
City of Hope Medical Center
Duarte, California, 91010, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Virginia Sun
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2015
First Posted
January 8, 2015
Study Start
January 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
September 25, 2015
Record last verified: 2015-09